Environmental Assessments

Triggered by Foodborne Illness

Environmental Assessment: 2013 Cyclosporiasis outbreak in Iowa and Nebraska – Findings and Recommendations November 2013 This repost documents the environmental assessment conducted August 12 – 19, 2013 in response to a 2013 multi-state foodborne illness outbreak of Cyclospora cayetanensis. Epidemiologic and traceback investigations by the states of Iowa and Nebraska, the CDC and the FDA linked salad mix supplied by Taylor Farms de Mexico to Olive Garden and Red Lobster restaurants, which are owned by Darden Restaurants, to the outbreak. Five ranches in Guanajuato, Mexico, were assessed as part of this assessment, as was the Taylor Farms de Mexico processing facility.

An environmental assessment is an investigation that is triggered by an outbreak of foodborne illness or a food contamination incident. The purpose of the assessment is to determine how the "environment" contributed to the introduction and transmission of pathogens or other hazards that caused illness or contamination. FDA works with the involved firm and the appropriate government agencies to explain the findings, including the potential preventive controls. FDA also determines if any regulatory action is needed with regard to the involved firm, or if information was learned during the assessment that warrants guidance to the industry as a whole or other measures. FDA considers it important to release environmental assessments it has conducted because they may be instructive to other stakeholders, especially when viewed as a collection of environmental assessments.

To read more about an environmental assessment, including when it’s conducted, who conducts it, what investigators look for, and how FDA uses this information, see below.

In a nutshell: FDA conducts environmental assessments to learn the probable cause(s) of an outbreak of foodborne illness or a food contamination event and uses that information to identify preventive controls to prevent reoccurrence of an outbreak or contamination event. When outbreaks or food contamination events do occur, quickly responding to minimize the number of people who become ill is the Agency’s first priority. But once an outbreak or contamination event is contained, learning the probable cause and identifying preventive controls that the firm can implement helps the Agency to achieve its long-term goal of preventing outbreaks of foodborne illness and food contamination events. As a collection, these environmental assessments also have value in identifying trends in probable causes and potential preventive controls that may be more broadly applicable to the industry.

What is an environmental assessment and does it differ from a routine outbreak investigation? An outbreak investigation involves immediately tracing foods implicated in illnesses and outbreaks back to their source, taking regulatory action if necessary to correct deficiencies, and identifying implicated product that may be in the marketplace so it can be recalled if necessary. An environmental assessment is an in-depth, multi-disciplinary, systems-based approach to determining how contamination may have occurred, and proliferated so it can be prevented in the future. In other words, how did the “environment” contribute to the introduction, transmission and proliferation of pathogens or other hazards that caused illness or contamination? An environmental assessment is different from an outbreak investigation. The complete system and the interactions of the pieces that make up the system are intensively studied, and the assessment generally extends beyond the location where the contamination was identified. The definition of “environment” will depend on where the investigation is carried out, but may involve in-depth assessments of factors such as air and water, soil, ingredients, climate, domestic and wild animals, equipment, company operating procedures and policies, and worker health, hygiene and training.

When is it conducted? An environmental assessment is not conducted for every foodborne illness outbreak or contamination event. Factors that are considered include whether a new hazard or pathogen/food combination is causing illness, whether product has been widely distributed, whether the assessment has the potential to identify new probable causes or preventive controls, the public health impact of the outbreak, and availability of FDA and other resources.

Who conducts the assessment? The investigation is conducted by a multi-disciplinary team that could involve local, state and federal government agencies as well as industry and scientific experts. Team members will vary depending on the setting and expertise needed but the team is usually led by a trained regulatory investigator and can include specialists such as microbiologists, epidemiologists, water quality experts, sanitation experts, food technologists, and veterinarians.

What does the team look for? Any point in the farm-to-table continuum can contribute to a foodborne illness, so investigators look at the main points on the continuum— 1) source (e.g., farm or fishery), 2) processing/packing/manufacturing, 3) distribution (warehousing), and point of final service or consumption.

The multi-disciplinary team will try to identify what factors most likely contributed to an outbreak (referred to as “contributing factors”), how they occurred (referred to as an “environmental antecedent” or “root cause”). They will also attempt to identify immediate and long-term steps (“control strategies”) that could be taken to reduce the risks identified. Multiple contributing factors, root causes, and control strategies could be identified during an environmental assessment.

For example, in a food establishment, a contributing factor may be poor personal hygiene, the root cause may be inadequate hand washing, and the control strategy may be employee training on proper hand washing and improved supervision to ensure consistent adherence to the hand washing procedures. At the production level, a contributing factor might be contaminated water, the root cause might be a failing sewage system that is contaminating the water, and a control strategy could involve redesigning the sewage system and implementing a maintenance schedule. At retail, a contributing factor may be an ill employee preparing food, the root cause could be lack of a policy to exclude sick employees from food preparation areas, and the corrective action could be to implement such a policy.

Step 1: Planning and preparation The team plans for the assessment by: (1) reviewing epidemiological information, laboratory results, and food facility information; (2) meeting to identify roles and responsibilities, intended outcomes, and ways the team will communicate during the site visit; (3) determining the need for and purpose of food and environmental sampling to be conducted, and (5) discussing recommended procedures for collecting, holding and transporting samples.

Step 2: Site visit During the site visit, the team will interview management about policies and procedures and interview food workers about how policies and practices are actually implemented. The team walks through the site to understand the physical layout and how it relates to food handling processes. They collect information on food handling processes and any variables that may have had a negative influence on the food safety system at the time of the outbreak. They collect food and environmental samples, focusing on hard-to-clean areas such as slicers and floor drains. The team examines information such as food source records, process monitoring logs, written policies for personal hygiene, facility design diagrams and recipes. Following the site visit, the team develops a hypothesis about the factors involved in the outbreak.

Step 3: Assess information The team selects the information that is most relevant and credible and analyzes it to test their hypotheses and identify variables that they believe contributed to the outbreak.

Step 4: Identify potential preventive control strategies These include immediate control strategies, such as making on-site corrections at the facility, stopping distribution of food, and closing the facility. Longer-term control strategies include: implementing preventive controls, training staff, recommending changes in suppliers, validating a heat process, and changing policies related to sick leave or personal hygiene.

Step 5: Complete investigative report The final report summarizes the investigation and includes factors that may have led to the outbreak, including contributing factors, root causes and identification of potential preventive controls.

How does FDA follow up on the findings in an environmental assessment? FDA works with involved firm and the appropriate government agencies to explain the findings, including the potential preventive controls. FDA also will determine if any regulatory action is needed with regard to the involved firm, or if information was learned during the assessment that warrants guidance to the industry as a whole or training for industry or federal, state and local regulators. In addition, the Agency shares the environmental assessment through this website because of the belief that it may be instructive to other stakeholders, especially when viewed as a collection of environmental assessments.